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10 Posts
Hello Everyone,
Can i seek your advise on this…
On recent review of past internal quality audit, a non-conformance #1324 was raised against overdue non-conformance #1269 due to no evidence of approved extension. The Quality Manager accepted the NC #1324 and responded with his RC/CA/PA as follows:
@ RC, "The auditor (who raised NC#1269) was ineffective in resolving the issue via email resulting to NC going overdue."
@ CA, "After counselling the auditor, the NC#1269 was closed'"
@"PA, "None. The cultural aspects influence how the auditor ineffectively dealt with NC."
I viewed the response of QM was inappropriate and out of context. Can i seek your opinion if this is acceptable response; if not, what is the best way to correct this QM?
----Cyrus
2 Replies
13 Posts
Hi Cyrus,
I am a Lead Auditor and need a bit more information, starting with how the QMS is structured. This reads as if the auditor is responsible for following the NC to closure in that system. Normally, RC/CA/PA and closure is the responsibility of the audited party. If the NC isn't resolved in the allotted time and is found unresolved in the next audit, the NC is against the system for a failure to follow its own procedure. Your statement reads as if the QM believes it was the responsibility of the auditor to manage NC 1269 to closure. That may be the case depending on how Internal Audit NC's are to be handled in that system.
However, the CA and PA are unacceptable to me. CA and PA for 1324 should have required an objective review and updating (if needed) of how NCs are handled systemically-such as escalation protocols.
CA and PA should never single out how a person acted (or didn't), they require systemic actions to limit personal error.
The QM should be counseled to look past "cultural aspects" and work to build an effective internal auditing system independent of personal or cultural bias. the audit is an evaluation of the system, not its people.
Mark Stevens
I am a Lead Auditor and need a bit more information, starting with how the QMS is structured. This reads as if the auditor is responsible for following the NC to closure in that system. Normally, RC/CA/PA and closure is the responsibility of the audited party. If the NC isn't resolved in the allotted time and is found unresolved in the next audit, the NC is against the system for a failure to follow its own procedure. Your statement reads as if the QM believes it was the responsibility of the auditor to manage NC 1269 to closure. That may be the case depending on how Internal Audit NC's are to be handled in that system.
However, the CA and PA are unacceptable to me. CA and PA for 1324 should have required an objective review and updating (if needed) of how NCs are handled systemically-such as escalation protocols.
CA and PA should never single out how a person acted (or didn't), they require systemic actions to limit personal error.
The QM should be counseled to look past "cultural aspects" and work to build an effective internal auditing system independent of personal or cultural bias. the audit is an evaluation of the system, not its people.
Mark Stevens
10 Posts
Hi Mark,
Thank you for your insights.
You're right. The RC/CA/PA of NC#1269 is responsibility of auditee, but the auditor is responsible to ensure NC#1269 is closed within allotted time.
In this scenario of Quality System audit, the QM is providing the RC/CA/PA response against NC#1324 which i also found inappropriate. The QM seems to have a personal issue with the Auditor the he cannot deal professionally. In turn, i guess it reflects on the QM ability to lead and manage its people and the quality system.
Regards
Cyrus
Thank you for your insights.
You're right. The RC/CA/PA of NC#1269 is responsibility of auditee, but the auditor is responsible to ensure NC#1269 is closed within allotted time.
In this scenario of Quality System audit, the QM is providing the RC/CA/PA response against NC#1324 which i also found inappropriate. The QM seems to have a personal issue with the Auditor the he cannot deal professionally. In turn, i guess it reflects on the QM ability to lead and manage its people and the quality system.
Regards
Cyrus
